Medtronic Issues Class I Recall for MiniMed Insulin Pumps Amid Battery Concerns; Boston Scientific Secures FDA Approvals; Weixin Medical's Vena Cava Filter Gains China Market Authorization

Oct 27, 2024 18:56 CST Updated 18:56

Medtronic

Medical Device Manufacturer

Recently, the U.S. Food and Drug Administration (FDA) announced that the battery recall of Medtronic's MiniMed 600 and 700 series insulin pumps has been classified as a Class I recall, the most serious type, indicating that the use of these devices may cause severe injury or even death.

Medtronic has long been aware of the battery life issues with insulin pumps. From January 2023 to September 2024, the company received 170 reports of hyperglycemia (blood glucose levels exceeding 400 mg/dL) and 11 reports of diabetic ketoacidosis in the United States, which may be related to battery problems.

According to the FDA's device recall database, Medtronic involved approximately 785,000 system products in the Class I recall events in October.

In response, Medtronic sent two safety alert letters to customers in July and October this year, reminding customers of its diabetes devices to pay attention to the built-in alarms and battery status of the pump, and informing customers to contact Medtronic immediately if they observe any changes in battery life.

Although it is a recall, Medtronic does not require users to return the MiniMed 600 and 700 series insulin pumps. Users should replace the battery immediately after receiving the "Low Battery Pump" alert and carry an extra battery with them in case of unexpected replacement needs. Meanwhile, Medtronic offers a 24-hour technical support team, ready to assist users at any time.

This incident provides an important lesson for the medical device industry. While insulin pumps, as a key tool in diabetes management, have brought great convenience to patients through improvements in design and functionality, the potential risks caused by battery issues also serve as a reminder to manufacturers and regulatory agencies that continuous monitoring and improvement of medical devices are crucial.

What "械" news in the medical device industry is worth paying attention to this week? Insights into new industry policies, observations of corporate developments, and a review of market investments and financing, all tracked and reported by the "Pharmaceutical Economy News"!

Insights into New Industry Policies

CMDE Seeks Public Comments on the "Guiding Principles for the Registration Review of Platelet-Rich Plasma Preparation Devices (Draft for Comments)"

On October 21, the Center for Medical Device Evaluation of the National Medical Products Administration released a notice soliciting public comments on the "Guiding Principles for the Registration Review of Platelet-Rich Plasma Preparation Devices (Draft for Comments)."

The scope of application clarified in the draft for comments includes platelet-rich plasma preparation devices managed as passive medical devices. These products are used to prepare autologous platelet-rich plasma from autologous blood samples for use as an adjuvant treatment in fracture surgeries. The prepared plasma is not intended for intravenous injection.

The key points of registration review include product design and development, regulatory information, summary documents, non-clinical data, clinical evaluation data, product instructions and label drafts, as well as quality management system documents. Particular emphasis is placed on the fact that product design and development should be clinically oriented, ensuring the safety and effectiveness of the manufacturing process while taking into account the requirements of medical device usability engineering.

The public and experts, scholars, production enterprises, and practitioners in relevant fields can provide feedback via email before November 20, 2024.

Chongqing Municipal Medical Products Administration Signs Strategic Cooperation Agreement with Meituan Health

To strengthen the supervision of online sales of drugs and medical devices and combat illegal activities, on October 22, the Chongqing Municipal Medical Products Administration signed a strategic cooperation agreement on quality and safety supervision of online sales of drugs and medical devices with Meituan Pharmaceutical Health in Chongqing.

Meituan, as a key online pharmaceutical purchasing platform, will play a crucial role in the regulation of pharmaceuticals and medical device quality. According to the agreement, the Chongqing Municipal Medical Products Administration will leverage its professional expertise to support Meituan in areas such as policy and regulation training, pharmaceuticals and medical device data sharing, and regulatory risk alerts, fostering a favorable development environment. Both parties will utilize their respective strengths to establish a diversified regulatory framework, advance "government-enterprise co-governance" in the quality and safety supervision of online pharmaceuticals and medical devices sales, enhance standardization, and protect consumer rights.

Observation of New Trends in Enterprises

Boston Scientific Two Medical Devices Receive FDA Approval for Market Launch

On October 21, Boston Scientific's FARAWAVE NAV Ablation Catheter with integrated navigation functionality and Faraview software received approval from the U.S. Food and Drug Administration (FDA).

The above two products have been officially launched in the United States. The FARAWAVE NAV ablation catheter is an upgrade based on the previous generation PFA product, FARAPULSE. It looks very similar to the FARAPULSE ablation catheter (FARAWAVE) in appearance, but the new generation product has many new functions that the previous generation did not possess — magnetic navigation function and a dedicated 3D FARAVIEW module (software).

FARAVIEW Software, Used with FARAWAVE NAV Ablation Catheter, Provides Doctors with an Intuitive Display of the Treatment Process. The software dynamically shows the catheter’s position, shape, and rotation, allowing doctors to clearly observe the specifics of the ablation.

Weixin Medical's Vena Cava Filter Approved for Marketing

Recently, the Caval Vein Filter developed by Weigao Intervention Group's subsidiary, Shandong Weixin Medical Device Co., Ltd. ("Weixin Medical" for short), has officially obtained the Medical Device Registration Certificate of the People's Republic of China issued by the National Medical Products Administration.

This product features an integrated mesh lantern-style filter structure, which offers excellent self-centering ability, enhances thrombus capture rate, and maintains long-term patency of the inferior vena cava. The filter is made of superelastic memory alloy and can self-expand upon release. Precision thread designs at both ends of the filter ensure dual-channel adjustability and control during release via the femoral or jugular vein, enabling precise positioning. The optimized design of the anchoring barbs prevents migration and facilitates retrieval. The multi-strand structure of the delivery cable ensures smooth device delivery and synchronized rotation. The approval and market launch of this product will provide clinicians with a safer and more controllable option for preventing PE, offering patients more secure and effective treatment outcomes.

Shuimu Jingchuang Helps Yunyi Star Plasma Surgical Device Get Approved for Marketing

On October 16, Shuimu Jingchuang assisted Yunyi Star (Shanghai) Technology Co., Ltd. ("Yunyi Star") in successfully obtaining the product registration certificate approved by the National Medical Products Administration (NMPA) for its self-developed "Plasma Surgical Device."

LYTNING Plasma Surgical Device, the Star of Sports Medicine, integrates cutting (ABLATE), coagulation (COAG), suction, manual control, and temperature measurement functions on a single electrode, showcasing its features in different working environments. The suction electrode offers excellent visibility and high cutting accuracy, used for the rapid removal of various soft tissues. In addition to removing air bubbles from the field of view, its powerful suction can draw small, freely floating tissues to the electrode, allowing surgeons to focus on their technique without worrying about free-floating soft tissues.

Market Investment and Financing Review

Raysmart Completes Over 100 Million Yuan in Series A Financing

On October 24, Suzhou Rayshape Intelligent Technology Co., Ltd. ("Rayshape Intelligent"), a comprehensive solution provider for dental 3D printing, announced the completion of an over 100-million-yuan Series A round of financing. This round of financing was led by Unity Investment, with investments from several senior entrepreneurs in the dental industry, and Index Capital serving as the exclusive financial advisor. The funds from this round will mainly be used for capacity expansion and overseas market development.

RACE Smart is a provider of integrated digital production solutions based on 3D printing, led by a founding team with over 10 years of experience in the 3D printing industry. This team has a complete capability spectrum, deep technical accumulation, and mature operational concepts. RACE Smart possesses full independent research and development capabilities, including AI-based solution design and material development, across all aspects of stereolithography 3D printing—such as optics, electrical systems, mechanics, software, algorithms, and materials. It offers comprehensive and leading integrated solutions for various industries and application scenarios, covering the development, production, and sales of 3D printing equipment, software, materials, and technical solutions.

Stellar Sea Medical Completes Over RMB 100 Million in Series B Financing

Recently, Shenzhen Star Sea Medical Technology Co., Ltd. (hereinafter referred to as Star Sea Medical) announced the completion of a B-round financing of over 100 million RMB, led by Vivo Capital, with continued investment from existing shareholders Legend Capital and Daotong Investment. Heryue Capital served as the exclusive financial advisor. This round of financing will help Star Sea Medical further expand its production capacity, accelerate new product development, and enhance its global market expansion, driving its rapid growth in the disposable endoscope field.

Stellar Sea Medical was founded in October 2020. The founding team comes from leading medical device companies both in and outside China, with over a decade of experience in minimally invasive surgical product development, global marketing, and production management. The company is committed to becoming an innovative leader in endoscopic interventional diagnosis and treatment. Its core products, disposable electronic endoscopes, cover fields such as urology, respiratory, ICU, gynecology, and gastroenterology, and have entered markets in China, the United States, Europe, and the Asia-Pacific region.

Okami Medical Completes $32.5 Million Financing

On October 21, Okami Medical announced the completion of a $32.5 million (approximately 227 million RMB) financing round, led by new investor Vensana Capital, with participation from US Venture Partners, members of the Okami board, and other senior figures in the medical device industry.

LOBO Vascular Occluder is an innovative medical device developed by Okami Medical. The system utilizes proprietary HDBRAID technology to provide a high-porosity density vascular occluder for the treatment of peripheral vascular diseases, such as peripheral bleeding, aneurysms, and tumor embolization. The LOBO Occluder has a porosity density four times higher than other braiding methods, with smaller pores, which helps significantly reduce blood flow, accelerating hemostasis and thrombosis formation.

Editor: Shuwen